Houston, we have a problem! [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2020-11-30 15:42 (733 d 15:39 ago) – Posting: # 22099
Views: 4,059

Dear Osama,

❝ Thank you for the brilliant explanation.


You are welcome! In the meantime I added more stuff to my post.
If my interpretation of the GL is correct (is it?) and applied as such by members of the GCC, we have a problem if the CVwR observed in the study is ≤30%.

What could be done?
  1. In the EU lots of accepted studies with 75.00–133.33%. Prior to 2001 limits of 70–143% were not uncommon for Cmax. Sometimes even for AUC…
  2. An often overlooked detail. Regularly difficult to provide for generic companies with no access to the originator’s data. Generally just a lot of :blahblah: in the protocol.

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